BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBLE DISTRACTION DEVICE

    MDR report key: 3782314 · Received April 30, 2014

    Report

    Report Number
    2520274-2014-11137
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 2, 2014
    Product Code
    MQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE WAS USED FOR TREATMENT AND NOT DIAGNOSIS. JOURNAL OF ORAL MAXILLOFACIAL SURG 2009. THIS REPORT IS FOR UNKNOWN MANDIBLE DISTRACTOR. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE RECEIVED CLINICAL APPLICATION OF CURVILINEAR CLINICAL APPLICATION OF CURVILINEAR DISTRACTION OSTEOGENESIS FOR CORRECTION OF MANDIBULAR DEFORMITIES LEONARD B. KABAN, DMD, MD, EDWARD B. SELDIN, DMD, MD, RON KIKINIS, MD, KRISHNA YESHWANT, BA,BONNIE L. PADWA, DMD, MD, AND MARIA J. TROULIS, DDS REPORTED A RETROSPECTIVE EVALUATION, THE PURPOSE WAS TO REPORT THE USE OF A SEMIBURIED CURVILINEAR DISTRACTION DEVICE, WITH A 3-DIMENSIONAL (3D) COMPUTED TOMOGRAPHY TREATMENT PLANNING SYSTEM, FOR CORRECTION OF MANDIBULAR DEFORMITIES. THE PURPOSE: THIS WAS A RETROSPECTIVE EVALUATION OF 13 CONSECUTIVE PATIENTS, WITH SYNDROMIC AND NONSYNDROMIC MICROGNATHIA, WHO UNDERWENT CORRECTION BY CURVILINEAR DISTRACTION OSTEOGENESIS. A 3D COMPUTED TOMOGRAPHY SCAN WAS OBTAINED FOR EACH PATIENT AND IMPORTED INTO A 3D TREATMENT PLANNING SYSTEM. POSTOPERATIVELY, PATIENTS WERE FOLLOWED BY CLINICAL EXAMINATION AND PLAIN RADIOGRAPHS TO ENSURE THE DESIRED VECTOR OF MOVEMENT. AT END DISTRACTION, WHEN POSSIBLE, A 3D COMPUTED TOMOGRAPHY SCAN WAS OBTAINED TO DOCUMENT THE FINAL MANDIBULAR POSITION. RESULTS: OF THE 13 PATIENTS, 8 WERE FEMALES AND 5 WERE MALES, WITH A MEAN AGE OF 11.9 YEARS (RANGE 15 MONTHS TO 39 YEARS). ALL 13 UNDERWENT BILATERAL MANDIBULAR CURVILINEAR DISTRACTION. OF THE 13 PATIENTS, 8 WERE 16 YEARS OLD OR YOUNGER AND 5 WERE YOUNGER THAN 6 YEARS OF AGE. THE DIAGNOSES INCLUDED TREACHERCOLLINS SYNDROME ( 3), NAGER SYNDROME (3), CRANIOFACIAL MICROSOMIA ( 2), POST-TRAUMATICANKYLOSIS (1), AND MICROGNATHIA (SYNDROMIC,( 3) NONSYNDROMIC, (1). THE CORRECT DISTRACTOR PLACEMENT, VECTOR OF MOVEMENT, AND FINAL MANDIBULAR POSITION WERE ACHIEVED IN 10 OF 13 PATIENTS. IN THE OTHER 3 PATIENTS, THE DESIRED JAW POSITION WAS ACHIEVED BY ¿MOLDING¿ THE REGENERATE. THE USE OF A SEMIBURIED CURVILINEAR DISTRACTION DEVICE, WITH 3D TREATMENT PLANNING, IS A POTENTIALLY POWERFUL TOOL TO CORRECT COMPLEX MANDIBULAR DEFORMITIES. IN 3 PATIENTS, DISTRACTOR PLACEMENT RESULTED IN A LESS-THAN-IDEAL JAW POSITION. THE DEVICES WERE REMOVED HALFWAY THROUGH THE FIXATION PERIOD, BEFORE COMPLETE BONE FORMATION. THE DESIRED JAW POSITION WAS ACHIEVED BY ¿MOLDING¿ THE REGENERATE AND IMMOBILIZING THE JAW UNTIL HEALING HAD OCCURRED. THESE 3 PATIENTS HAD NOT HAD THE BENEFIT OF PLANNING WITH THE 3D MODEL AND ACRYLIC TEMPLATE, WHICH ELIMINATED THIS PROBLEM IN SUBSEQUENT CASES. IN 1 PATIENT, 1 OF THE DEVICES FAILED AFTER DISTRACTION WAS COMPLETED. DURING THE FIXATION PERIOD, THE DEVICE TURNED BACK ON ITSELF, AND THE JAW POSITION REGRESSED. THIS DEVICE WAS USED FOR TREATMENT AND NOT DIAGNOSIS. THIS REPORT IS FOR A PATIENT WHERE THE DEVICE FAILED AFTER DISTRACTION WAS COMPLETED AND DURING THE FIXATION PERIOD THE DEVICE TURNED BACK ON ITSELF AND THE JAW REGRESSED. THIS IS ONE OF TWO COMPLAINTS FOR (B)(4) FOR A UNKNOWN MANDIBLE DISTRACTION DEVICE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259974 MANDIBLE DISTRACTION DEVICE MQP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other